Flag of the European Union EU Clinical Trials Register Help

Clinical trials for TachoSil

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44334   clinical trials with a EudraCT protocol, of which   7366   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     
    29 result(s) found for: TachoSil. Displaying page 1 of 2.
    1  2  Next»
    EudraCT Number: 2007-007254-62 Sponsor Protocol Number: TC-029-IM Start Date*: 2008-07-01
    Sponsor Name:Nycomed Danmark ApS
    Full Title: Non-randomised, open, multi-center trial evaluating feasibility and safety of TachoSil application on a colorectal anastomosis.
    Medical condition: The scope of this trial is to evaluate if it is possible to apply TachoSil around colorectal anastomosis and evaluate its feasibility in future clinical trials. Therefore the only focus is on the v...
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Completed) DE (Completed) GB (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2011-003115-34 Sponsor Protocol Number: V1 Start Date*: 2012-06-06
    Sponsor Name:Medizinische Universität Wien
    Full Title: A Collagen-Fibrin Patch (Tachosil®) for the Prevention of Symptomatic Lymphoceles after Pelvic Lymphadenectomy in Women with Gynecologic Malignancies: a Randomized Clinical Trial
    Medical condition: endometrial cancer, cervical cancer
    Disease:
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: AT (Completed)
    Trial results: View results
    EudraCT Number: 2004-005028-42 Sponsor Protocol Number: TC-019-IN Start Date*: 2006-03-03
    Sponsor Name:Nycomed Danmark ApS
    Full Title: A prospective, multi-centre, phase III-b study of TachoSil in paediatric patients scheduled for resection of the liver with or without segmental liver transplantation
    Medical condition: Paediatric patients (age above 4 weeks and below 6 years) undergoing surgical resection of the liver with or without segmental liver transplantation
    Disease:
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: GB (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2016-001191-30 Sponsor Protocol Number: IISR-2015-101127 Start Date*: 2017-04-25
    Sponsor Name:Department of Obstetrics & Gynecology, Copenhagen University Hospital, Rigshospitalet
    Full Title: Use of TachoSil® for the prevention of postoperative complications after groin dissection in vulva cancer patients
    Medical condition: Vulva cancer
    Disease: Version SOC Term Classification Code Term Level
    19.1 100000004864 10047750 Vulval neoplasms malignant HLT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: DK (Completed)
    Trial results: View results
    EudraCT Number: 2011-005749-10 Sponsor Protocol Number: NL38212 Start Date*: 2012-08-01
    Sponsor Name:University Medical Center Utrecht
    Full Title: Safety and Feasibility of TachoSil®: Application on Esophageal Anastomoses. A non-randomized single center study.
    Medical condition: Anastomotic leakage
    Disease: Version SOC Term Classification Code Term Level
    14.1 10022117 - Injury, poisoning and procedural complications 10065961 Esophageal anastomotic leak LLT
    14.1 10022117 - Injury, poisoning and procedural complications 10065890 Oesophageal anastomotic leak LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2005-004429-25 Sponsor Protocol Number: TS-001-DK Start Date*: 2006-10-31
    Sponsor Name:Viborg Sygehus
    Full Title: A single cohort, open trial to evaluate the efficacy and safety of TachoSil in prevention of seroma formation following axillary lymph node dissection in women following surgery for breast cancer. ...
    Medical condition: Seroma formation in the axilla following axillary dissection of lymphnodes following surgery for breast cancer in women
    Disease: Version SOC Term Classification Code Term Level
    7.1 10040102 LLT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: DK (Completed)
    Trial results: (No results available)
    EudraCT Number: 2008-005549-46 Sponsor Protocol Number: TS-005-DK Start Date*: 2009-01-21
    Sponsor Name:Hvidovre Hospital
    Full Title: A randomised, controlled prospective open parallel groups clinical trial for the evaluation of efficacy and safety of TachoSil® in women undergoing hysterectomy. A pilot study
    Medical condition: It is the intention with this clinical trial to evaluate wheter TachoSil may reduce the formation of postoperative haematomas on the vaginal cuff following hysterectomi. The presence of a postopera...
    Disease: Version SOC Term Classification Code Term Level
    9.1 10044080 Total abdominal hysterectomy LLT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: DK (Completed)
    Trial results: (No results available)
    EudraCT Number: 2012-005653-22 Sponsor Protocol Number: NL13PAR Start Date*: 2014-08-25
    Sponsor Name:Netherlands Cancer Institute-Antoni van Leeuwenhoek Hospital [...]
    1. Netherlands Cancer Institute-Antoni van Leeuwenhoek Hospital
    2. Takeda Nederland B.V.
    Full Title: TachoSil patch application as replacement of closed suction wound drainage by parotid gland surgery; a prospective study.
    Medical condition: The surgical procedure of parotidectomy whereby a protid tumor is removed. During this procedure the wound surface will be covered by the surgical sealing patch TachoSil instead of the use of a c...
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2004-002380-24 Sponsor Protocol Number: TC-021-IM Start Date*: 2005-12-29
    Sponsor Name:Nycomed Danmark ApS, International Medical Affairs
    Full Title: An open randomised, prospective, multi-centre, parallel-group trial to compare efficacy and safety of TachoSil versus standard surgical treatment in patients undergoing pulmonary lobectomy for lung...
    Medical condition: Management of pulmonary air leakage following lobectomy in subjects with lung malignancies including metastases.
    Disease: Version SOC Term Classification Code Term Level
    8.1 10024741 PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Completed) HU (Completed) DE (Completed) DK (Completed) SE (Completed) BE (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2013-000782-36 Sponsor Protocol Number: AGO/2013/002 Start Date*: 2013-08-13
    Sponsor Name:Ghent University Hospital
    Full Title: Effect of TachoSil® on incidence of symptomatic and radiographic lymphoceles after extended pelvic lymph node dissection in prostate and bladder cancer.
    Medical condition: Patients with prostate cancer or bladder cancer, undergoing transperitoneal pelvic lymph node dissection.
    Disease: Version SOC Term Classification Code Term Level
    14.1 100000004865 10057890 Lymph node dissection LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2006-003349-17 Sponsor Protocol Number: TS-003-DK Start Date*: 2007-08-13
    Sponsor Name:Hvidovre Hospital
    Full Title: Applicability of TachoSil® in sealing rectal anastomoses. A feasibility trial.
    Medical condition: Sealing of rectal anastomoses following surgery for colo-rectal cancer.
    Disease: Version SOC Term Classification Code Term Level
    9.1 10061451 Colorectal cancer LLT
    Population Age: Gender: Male, Female
    Trial protocol: DK (Completed)
    Trial results: (No results available)
    EudraCT Number: 2006-000028-15 Sponsor Protocol Number: TC-023-IM Start Date*: 2007-01-26
    Sponsor Name:Nycomed Danmark ApS
    Full Title: A randomised, open label, parallel-group, multi-centre trial to compare the efficacy and safety of TachoSil versus standard haemostatic treatment in the cardiovascular surgery
    Medical condition: Supportive haemostatic treatment in patients having elective surgery on the heart, the ascending aorta or arch, requiring pulmonary bypass procedure.
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) FR (Completed) DK (Completed) IT (Completed) ES (Completed)
    Trial results: View results
    EudraCT Number: 2017-003931-12 Sponsor Protocol Number: BXU513667 Start Date*: 2017-12-13
    Sponsor Name:Baxter Healthcare Corporation
    Full Title: A Randomized Controlled Non-inferiority Study to Evaluate the Efficacy and Safety of Hemopatch Compared to TachoSil in Preventing or Reducing Postoperative Air Leaks After Pulmonary Resection.
    Medical condition: Postoperative air leakage.
    Disease: Version SOC Term Classification Code Term Level
    20.0 10038738 - Respiratory, thoracic and mediastinal disorders 10067826 Pulmonary air leakage PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Completed) ES (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2015-000091-10 Sponsor Protocol Number: 2014121566 Start Date*: Information not available in EudraCT
    Sponsor Name:Rigshospitalet, department of surgical Gastroenterology, C-Tx
    Full Title: RCT-comparison of two hemostatic devices (Hemopath vs. Tachosil) in liver resection.
    Medical condition: Bleeding during liver resection and the efficacy of 2 types of hemostatic patches on this, thus all diagnosis' that require liver resection.
    Disease: Version SOC Term Classification Code Term Level
    17.1 100000004865 10060663 Surgical hemostasis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DK (Completed)
    Trial results: (No results available)
    EudraCT Number: 2013-000639-29 Sponsor Protocol Number: ABCSG_P00 Start Date*: 2013-03-27
    Sponsor Name:ABCSG (Austrian Breast & Colorectal Cancer Study Group)
    Full Title: A prospective, open, randomized, academic phase II, two-arm trial evaluating the effect of fibrin-coated collagen (TachoSil®) on postoperative pancreatic leakage and fistula formation from the panc...
    Medical condition: pancreatic surgery - evaluation of the effect of fibrin-coated collagen
    Disease: Version SOC Term Classification Code Term Level
    18.0 10017947 - Gastrointestinal disorders 10049192 Pancreatic fistula PT
    18.0 100000004863 10050457 Pancreatic anastomotic leak LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Completed)
    Trial results: View results
    EudraCT Number: 2009-012994-37 Sponsor Protocol Number: TACO1 Start Date*: 2009-12-13
    Sponsor Name:UNIVERSITA` CAMPUS BIOMEDICO
    Full Title: RANDOMISED PROSPECTIVE TRIAL: PREVENTION OF PANCREATIC FISTULA AFTER PANCREATICO-DUODENECTOMY USING BIOLOGICAL SEALANT
    Medical condition: - patients underwent pancreatico-duodenectomy with pancreatico-jejunal anastomosis
    Disease: Version SOC Term Classification Code Term Level
    9.1 10042613 SOC
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2014-000816-32 Sponsor Protocol Number: FC-005 Start Date*: 2014-10-17
    Sponsor Name:ProFibrix, A wholly owned subsidary of the Medicines Company
    Full Title: A Phase 3b, Randomized, Single-Blind, Controlled, Comparative Efficacy and Safety Study of Topical Fibrocaps™ (Raplixa™) and Tachosil® in Surgical Hemostasis during Hepatic Resection
    Medical condition: Hepatic surgery specifically, hepatic wedge resection or anatomic resection of 1 to 5 contiguous hepatic segments, and/or other hepatic surgery, any of which may be combined with other surgical pro...
    Disease: Version SOC Term Classification Code Term Level
    18.0 100000004865 10053001 Surgical haemostasis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) AT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2007-003622-18 Sponsor Protocol Number: TS-004 Start Date*: 2007-10-01
    Sponsor Name:State University Hospital
    Full Title: Efficacy and safety of TachoSil in patients undergoing cystectomy. A pilot study.
    Medical condition: The trial will evaluate the efficacy and safety of TachoSil in patients undergoing cystectomy for bladder cancer and non-malignant bladder disease. TachoSil will be applied to the anastomoses betwe...
    Disease: Version SOC Term Classification Code Term Level
    9.1 10005003 Bladder cancer LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DK (Completed)
    Trial results: (No results available)
    EudraCT Number: 2009-013056-71 Sponsor Protocol Number: TC-2402-038-SP Start Date*: 2010-03-10
    Sponsor Name:Takeda Pharma A/S
    Full Title: TachoSil versus current practice in dura sealing techniques for the prevention of post-operative cerebrospinal fluid (CSF) leaks in patients undergoing skull base surgery: An open label, randomised...
    Medical condition: Skull base surgery for the prevention of postoperative cerebrospinal fluid (CSF) leaks
    Disease: Version SOC Term Classification Code Term Level
    14.1 10042613 - Surgical and medical procedures 10067908 Neurosurgery PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed) FR (Completed) FI (Prematurely Ended) SE (Completed) DE (Completed) NL (Completed) GR (Completed) ES (Completed) AT (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2008-006001-16 Sponsor Protocol Number: HVF-001-2008 Start Date*: 2008-12-10
    Sponsor Name:AZIENDA UNITA` SANITARIA LOCALE LECCE
    Full Title: Efficacy of TachoSil on air leakage in chest surgery
    Medical condition: Patient undergone lobectomy or segmentectomy (anatomical segmentectomy) for lung carcinoma and that during intraoperative phase after first suture with stapler show air leakage with grade 1-2 accor...
    Disease: Version SOC Term Classification Code Term Level
    9.1 10038738 SOC
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: (No results available)
    Download Options:
    Number of Trials to download:
    Download Content:
    Download Format:
    Note, where multi-state trials are shown in search results, selecting "Full Trial details" will download full information for each of the member states/countries involved in the trial.
    1  2  Next»
    Query did not match any studies.
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Sat May 03 20:28:25 CEST 2025 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA